MAUDE Adverse Event Report: ARTHREX, INC. DBL LD DX FBR TK W/BLK, 0.9MM ST NDLS; NON-DEGRADABLE FIXATION FASTENER

Model Number	DBL LD DX FBR TK W/BLK, 0.9MM ST NDLS
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/22/2021, it was reported by a sales representative via email that an ar-8990st-2 dx fibertak was inserted through a 1.6mm prepared bone tunnel and after it passed through the cortex, it was discovered that the forks on the inserter device had shredded the sutures bundle.This was discovered during a revision of a failed cmc internal brace on (b)(6) 2021.Surgeon redirected tunnels and used a single-loaded fibertak dx to complete procedure.Additional information received 12/23/2021.There were not arthrex devices explanted.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during insertion.As no further investigation was able to be performed no change in harm was identified.

• Brand Name: DBL LD DX FBR TK W/BLK, 0.9MM ST NDLS
• Common Device Name: NON-DEGRADABLE FIXATION FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19330978
• Report Number: 1220246-2024-03390
• Device Sequence Number: 20537147
• Product Code: MBI
• UDI-Device Identifier: 00888867377370
• UDI-Public: 00888867377370
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: DBL LD DX FBR TK W/BLK, 0.9MM ST NDLS
• Device Catalogue Number: AR-8990ST-2
• Device Lot Number: 14318767
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown